- November 2, 2021
The Food and Drug Administration (FDA or Agency) held a virtual public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2023 through 2027. The public meeting was held on November 2, 2021, at 9:00 a.m. (ET). The meeting included opening remarks, background on BsUFA, an overview of the proposed recommendations for reauthorization, industry perspectives on the recommendations, and public comments. Members of the public that wished to provide a public comment submitted a request online in advance of the meeting.
Though the meeting has concluded, the public docket is open until December 2, 2021. FDA encourages members of the public to submit their perspective on the proposed recommendations for BsUFA to the public docket. Please visit the Federal Register Notice and click on “Submit a Formal Comment” to submit your perspective.
The meeting was held in virtual format only, at https://fda.zoomgov.com/j/1610478285?pwd=MG1lN2hrYzBVTGhsd1F2eVhwZG1DQT09. Registration was available at this link on Eventbrite.
The meeting recording can be accessed at https://fda.zoomgov.com/rec/share/wVA_4pIF966LQxyBw61gNwOZ-ezQuqXTszESPWwKERIVekY3b53NO0VBmx-mQR6h.q5XbwJY2ilRMjGHn.
EVENT POINT OF CONTACT
Emily Ewing, Emily.Ewing@fda.hhs.gov, Center for Drug Evaluation and Research, Food and Drug Administration